Research and Institutional Review Board

Applying for Approval for Research Involving Human Subjects

Investigators wishing to conduct research under the auspices of the Institute and/or to study populations of the Institute must apply for and receive IRB approval prior to the commencement of research. Materials submitted for review must include the "Application for Review of Research Involving Human Subjects".

Previous to any such submission for IRB approval, the Office of the Institute Director must approve the research topic.

Investigators will be informed in writing of the results of the IRB's review. Approval by the IRB does not ensure access to subject populations.

Approved research is reviewed annually. Renewal forms are sent to the principal investigator three months prior to the end of the approved period. It is, however, the investigator's responsibility to ensure that the request for renewal is received by the IRB in a timely fashion. In addition, it is the responsibility of the investigator to report unanticipated issues involving risks to subjects or other problems to the IRB Chair, Jacqueline McCaffrey, or to the IRB Executive Secretary, Richard Herman, for evaluation. Any amendment or revision to the approved research design must be submitted to the IRB for review prior to implementation.

All researchers seeking IRB approval must first complete an on-line training program, "Human Participant Protections Education for Research Teams" at http://phrp.nihtraining.com/users/login.php (or an equivalent course).

Order of submission for Investigators:

Application to the Office of the Institute Director for approval of topic and notification

Completion of approved course on Human Subjects Research (or equivalent)